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Par Recalls 7 Treprostinil Lots

[ Price : $8.95]

Endos Par Pharmaceutical recalls seven lots of treprostinil injection 20g/20mL due to the potential for the presence of silicone p...

Info Collection on FDA Social/Behavioral Research

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Federal Register notice: FDA seeks comments on an information collection extension entitled Data To Support Social and Behavioral ...

PhRMA Wants More Feedback on Innovative Trials

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Pharmaceutical Research and Manufacturers of America urges FDA to hold more meetings on innovative clinical trial approaches to al...

Draeger Recalls Perseus Anesthesia Device

[ Price : $8.95]

Draeger Medical recalls its Draeger Perseus A500 Anesthesia Workstation due to the potential for an unexpected shutdown while oper...

Boxed Warning Ordered on CAR T-Cell Therapies

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FDA orders a Boxed Warning to highlight the serious risk of T cell malignancies following administration of BCMA-directed or CD-19...

Cochlear Osia Cleared for Younger Children

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FDA clears a Cochlear 510(k) to lower the patient age for its Cochlear Osia System from 12 years to five years for children with c...

Alvotech/Tevas Stelara Biosimilar Approved

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FDA approves Alvotech and Teva Pharmaceuticals Selarsdi (ustekinumab-aekn) injection for subcutaneous use, a biosimilar to Johnson...

Takedas Entyvio OKd for Crohns Maintenance

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FDA approves Takedas Entyvio (vedolizumab) subcutaneous administration for maintenance therapy in adults with moderately to severe...

AdvaMed Seeks Clarification on Ethnicity Data in RWE

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The Advanced Medical Technology Association says FDAs draft guidance on diversity plans for clinical trials needs to address what ...

Rinvoq Shows Promise in Arteritis: AbbVie

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AbbVie reports positive top-line results from SELECT-GCA, a Phase 3, placebo-controlled study that showed the companys arthritis d...